Home › Device types › GWJ
Stimulator, Auditory, Evoked Response
FDA product code GWJ · Class 2 · Neurology
1,038
Registered devices
119
Adverse events
4
Recalls
76
510(k) clearances
Devices with this code
Ear Tip ET-S10 Pack/250 pcs. — PATH medical GmbHOtoport/Otocheck Mini-Printer Cable — OTODYNAMICS LIMITEDGN Otometrics A/S — Natus Medical Denmark ApSGN Otometrics A/S — Natus Medical Denmark ApSJelly Tab Sensors — Natus Medical Denmark ApSGN Otometrics A/S — Natus Medical Denmark ApSFOAM large TEOAE probe tips — OTODYNAMICS LIMITEDOtoport Charger V2 — OTODYNAMICS LIMITEDPatient Response Button — PATH medical GmbHCARESCAPE B450 — GE Healthcare Finland OyEar Tip ET-03 Pack/50 pcs. — PATH medical GmbHEar Tip IT-01 Pack/100 pcs. — PATH medical GmbHBone Conductor BC-2LD — PATH medical GmbHSierra Summit — CADWELL INDUSTRIES, INC.Natus — NATUS MEDICAL INCORPORATEDEar Tip PM012 Pack/100 pcs. (Grason) — PATH medical GmbHEar Tip ET-10 Pack/100 pcs. — PATH medical GmbHNATUS MEDICAL — NATUS MEDICAL INCORPORATEDIntegrity Insert Earphones — Vivosonic IncNIM-ECLIPSE® — MEDTRONIC XOMED, INC.Otocheck - ABR Screener — OTODYNAMICS LIMITEDEar Tip ET-S11 Pack/100 pcs. — PATH medical GmbHAccessory Box AB08 — PATH medical GmbHAlgo 3i — Natus Medical Denmark ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE a |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) prema |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.